FDA Adverse Event
Malfunction
Summary report: N
TVL ADX
MDR report key: 3890560
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-04454
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- December 19, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED DURING A GENERATOR CHANGEOUT, IT WAS DISCOVERED EPISODES OF ABORTED THERAPIES WERE DUE TO LEAD NOISE. THE LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30234 | TVL ADX | DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL INC., CRMD | 1559/65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |